Abbott Sr. Specialist Regulatory Affairs in Singapore, Singapore

JOB DESCRIPTION:

Major Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

  • Core job responsibilities for this function may include:

  • Strategic Planning:

  • Assist in SOP development and review

  • Provide regulatory input to product lifecycle planning

  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes

  • Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval

  • Determine trade issues to anticipate regulatory obstacles

  • Determine and communicate submission and approval requirements

  • Participate in risk-benefit analysis for regulatory compliance

  • Premarket:

  • Monitor applications under regulatory review

  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies

  • Assist in preparation and review of regulatory submission to authorities

  • Postmarket:

  • Maintain annual licenses, registrations, listings and patent information

  • Assist compliance with product postmarketing approval requirements

  • Assist in the review of advertising and promotional items

  • Assess external communications relative to regulations

  • Review regulatory aspects of contracts

  • Assist with label development and review for compliance before release

  • Submit and review change controls to determine the level of change and consequent submission requirements

  • Contribute to the development and functioning of the crisis/ issue management program

  • Ensure product safety issues and product-associated events are reported to regulatory agencies

  • Provide regulatory input for product recalls and recall communications

Education:

  • Bachelor's degree in science. Preferred in biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical.

  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Experience:

  • 5-7 years of experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

JOB FAMILY:

Regulatory Operations

DIVISION:

ANI International Nutrition

LOCATION:

Singapore > Singapore : DUO Tower

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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